Labac Systems, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Labac Systems, Inc.” (first 1992, latest 1994), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 116 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IOR | Wheelchair, Mechanical | 6 | 6 |
| KNN | Components, Wheelchair | 3 | 3 |
| ITI | Wheelchair, Powered | 2 | 2 |
Review panels
- Physical Medicine (11)
Most recent Labac Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K941157 | BASIC RECLINE CHAIR | IOR | 1994-04-07 | 27 |
| K934418 | BASIC TILT CHAIR ( BTC ) | IOR | 1994-01-07 | 116 |
| K932639 | MANUAL TILT RECLINE CHAIR (MTC) | IOR | 1993-07-22 | 50 |
| K923362 | REDUCED SHEAR OWR RECLINE SYSTEM | ITI | 1993-03-26 | 261 |
| K923363 | ADJUSTABLE SLIDING BACK POWER RECLINE SYSTEM | ITI | 1993-03-24 | 259 |
| K921028 | MANUAL RECLINING CHAIR | IOR | 1993-03-24 | 386 |
| K923364 | TILT ADJUSTABLE SLIDING BACK RECLINE SEATING SYST | KNN | 1993-03-22 | 257 |
| K925272 | PEDIATRIC TILT CHAIR | IOR | 1993-02-12 | 116 |
| K923366 | TILT SEATING SYSTEM | KNN | 1993-02-12 | 219 |
| K921136 | MANUAL TILT CHAIR | IOR | 1992-04-02 | 23 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Labac Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Labac Systems, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Labac Systems, Inc.” (first 1992, latest 1994), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Labac Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Labac Systems, Inc. is 116 days.
Which FDA product codes appear under Labac Systems, Inc.?
The most frequent FDA product codes under this applicant name are IOR (Wheelchair, Mechanical, 6); KNN (Components, Wheelchair, 3); ITI (Wheelchair, Powered, 2).
Next steps
- See all 11 Labac Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IOR, Labac Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.